FILLING, STOPPERING

AND CAPPING MACHINES

 FILLING, STOPPERING
AND CAPPING MACHINES

The modern design of STERILINE filling, stoppering and

capping machines takes into consideration the newest
requirements of the filling process:

• In line transport and small width, suitable for the

application of open RABS , closed RABS and isolators,
reduce the volume to be monitored and sterilized, and
make reachable, from the operator front, any point of
the machine by gloves;
• Tight mechanisms, actuated from the mechanical
volume, fulfil the closed RABS and isolators tightness
requirements;
• Rotating table designed to achieve easily the
unidirectional and laminar air flow, reducing the
presence of particles on the table;
• Continuous monitoring of the viable and non viable
particles;
• Filling by peristaltic pumps and/or volumetric pumps
actuated by brushless motors, that allow precise filling
volume and easy adjustment of the pumps by means of
the HMI;
• Nitrogen blowing inside the vials before, during and
after the filling;
• 100% IPC (In Process Control) of the weight and
statistical Check Weighing system with feedback to the
dosing pumps;
• Possibility of performing prefilled syringes, loaded from
the nests;
• Vibration generator for the bowl of stoppers inside the
mechanical volume, below the process area;
• Capping designed to reduce particle generation, by
rotating the glassware under the blades.

STERILINE filling machines
series handle from 2ml to 100ml vials,
with minimal format changes and with
production speeds up to 300 vials/min,
according to vial size and filling volume.
The filling machines are equipped with
an infeed rotating table which feeds
empty vials into the walking beam
system.
The pumps in the filling section fill the
VFM correct dosage into the vials. Filling
operations are carried out in two steps
by means of a stainless steel dosing
nozzle mounted on an AISI316L
stainless steel support.
To avoid foaming, the filling system
utilizes a diving nozzle that, during the
filling operation, is retracted upward.
Each vial can be individually weighed
before and after filling to get the net
fill weight. A feedback control loop
can also be provided to automatically
adjust the filling volume of each
individual filling nozzle. For high speed
filling machines, a statistical check
weighing system is foreseen.
Vials proceed to the stopper inserting
station where stoppers are fed by a
vibratory feeder bowl to the stoppering
unit.
 1360 mm
1920 mm
The vials are stoppered by a pick-
and-place system, vacuum assisted.
A sensor detects the stopper presence;
VFM 50
746 mm
a fully seated position or partially
seated for products which require
lyophilization. The machine can handle
all standard stopper sizes: 13mm,
20mm, 28mm, 32mm.
In the STERILINE filling, stoppering and
capping machines VFCM series, the
consequently the machine rejects the aluminum cap sealing is on the same
un-stoppered vials. platform and it is performed by rotating
Stopper may be positioned in either blade and rotating vial system.

This results in an ideal closure without
disturbance of the laminar air flow
over the vials and without generating
any significant level of particles.
Automatic seal pressure control and
rejection are available.
For vials which need to be capped
after lyophilization, the capping unit
can be reloaded from the rotating
table through a special tray unloading
VFCM 100-S
system. The filling and stoppering
stations are switched off, while the
crimping station caps and seals the
lyophilized vials.
STERILINE filling machines VFM-S
series perform as well Pre Filled
Syringes (PFS) from 1ml to 20ml, with
minimal format changes, and with
production speed up to 120 PFS/min.
The stainless steel guides and the Delrin
contrast plate enable the operator to
load the PFS from the nests. The chute
brings the PFS into the infeed star-
wheel that loads the walking beam.
The chute is equipped with a minimum
load sensor to stop the machine when
PFS are missing.
The walking beam transports the PFS
through the pre-gas station, the filling
 3355 mm

942 mm
1591 mm

station and the post-gas station. STERILINE filling machines are

In the bung insertion station the star-
wheel handles bung stoppers fed by
a vibratory feeder bowl and special
double pistons insert the bung
stoppers into the PFS. Incomplete
syringes, without bung stopper, will be
automatically rejected.
designed to be integrated with our
superior containment systems: RABS,
cRABS and Isolators.
STERILINE filling machines can be
fully integrated with our washing
machines, depyrogenating tunnels
and external decontaminating
machines for a complete solution as
well as supplied stand alone.
The filling unit is designed to accept 4 volumetric pumps.
The basic machine is supplied with one set of two high
precision pumps for a single filling process. Two additional
pumps can be supplied for a two step filling.
Pumps are made of two AISI316L stainless steel parts:
the rotating piston and the cylinder. The parts are driven
by servo motors with the following advantages:
• Self-priming is possible without running the machine;
• In case of suspension, product can be continuously
recirculated during the machine stop;
• No vial - no fill is achieved without application of any
additional device such as valves, etc.;
• Independent adjustment and fine tuning for every single
pump;
• Stroke setting can be saved in the recipe and easily
loaded with every size change.
• The filling accuracy is +/- 0.5% for 1ml filling volume
and more, +/- 1.0% or better for less than 1ml filling
volume.
STERILINE integrated 100% IPC in-line check
weighing system is designed to detect the net
weight of all vials in a batch.
The system is composed of tare weight cells
and gross weight cells. The cells are mounted
on different supports, separated from the
machine frame, in order to eliminate any
vibration influence on the weighing process.
Parameters, such as target weight and
tolerances, can be set from the HMI and saved
in the recipes.
When the filling volume is out-of tolerance, the
vial is automatically rejected.
 Issued July 2013 by

STERILINE srl - Via Tentorio, 30 - 22100 Como - ITALY

Ph. +39 031 592 064 - Fax +39 031 591 976 - www.steriline.it